1、ISO/TS16949:2002 中英文对照 Quality management systems - Automotive suppliers - Particular requirements for the application of ISO 9001:2000质量管理体系汽车产品供应商ISO9001:2000 对汽车行业的特殊要求1Scope1 范围1.1 General1.1 总则ISO 9001:2000, Quality management systems - RequirementsISO 9001:2000质量管理体系-要求1 Scope1 范围1.1 General1.
2、1 总则This International Standard specifies requirements for a quality management system where an organization本标准为有下列需求的组织规定了质量管理体系的要求：a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, anda)证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；b) ai
3、ms to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.b)通过体系的有效应用，包括持续改进和预防不合格的过程而达到顾客满意。NOTE In this International Standard,
4、the term “product” applies only to the product intended for, or required by, a customer.注：在本标准中，术语 产品 仅适用于预期提供给顾客或顾客所要求的产品。This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design/development, production and, when relevant, in
5、stallation and servicing of automotive-related products.本技术规范与 ISO9001：2000 相结合，规定了用于汽车相关产品的设计与开发、生产，安装和服务（若有关时）的质量管理体系要求。This Technical Specification is applicable to production and service part organization sites where customer specified products are manufactured.本技术规范适用于组织的顾客指定生产件或服务件的制造现场。Remote
6、 locations such as design centres, corporate headquarters and distribution centres as they support the site form part of the site audit, but cannot obtain stand-alone certification to this Technical Specification.现场或外部的支持功能，（例如设计中心、公司总部和配送中心），构成现场审核的一部分，但不能独立获得关于本技术规范的认证。This Technical Specification
7、 can also be applied throughout the automotive supply chain.本技术规范也适用于整个汽车供应链。1.2 Application1.2 应用ISO 9001:2000, Quality management systems - RequirementsISO 9001:2000质量管理体系-要求1.2 Application1.2 应用All requirements of this International Standard are generic and are intended to be applicable to all or
8、ganizations, regardless of type, size and product provided.本标准所有规定的要求是通用的，旨在适用于不同其类型、规模和提供的产品所有组织。Where any requirements) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.当本标准中任何的要求因组织和其产品的特点而不适用时，可以考虑对其进行删减。W
9、here exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable
10、regulatory requirements.除非删减仅限第 7章中那些不会影响组织提供符合顾客和适用的法规要求产品的能力或职责任的要求，否则不能声称符合本标准The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.本技术规范中，当组织没有产品设计和开发职责，只有 7.3中有关的部分是允许的删减。Permitted exclusions do
11、not include manufacturing process design. For vehicles assembly plants, the authorized exclusions will be prescribed by IATF.允许的删减不包括制造过程的设计。2 Normative reference2 引用标准The following normative document contains provisions, which, through reference in this text, constitute provisions of this Technical
12、 Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent edition of the normative document in
13、dicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.通过在本标准中的引用，下列标准包含了构成本标准规定的内容。对标时间版本明确的引用标准，该标准的增补或修订不适用。但是，鼓励使用本标准的各方探讨适用下列标准最新版本的可能性。对于未标时间的引用标准，有关最新版是适用的。IS
14、O 及 IEC 成员保持现有有效的国际标准的注册地位。ISO 9000 :2000, Quality management systems - Fundamentals and vocabulary.ISO 9000：2000 质量管理体系基本原理和术语3 Terms and definitions3 术语和定义ISO 9001:2000, Quality management systems - RequirementsISO 9001：2000 ，质量管理体系-要求3 Terms and definitions3 术语和定义For the purposes of this Internat
15、ional Standard, the terms and definitions given in ISO 9000 apply.为了本国际标准的目的，ISO9000 中给出的术语和定义适用。The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:本版 ISO 9001标准描述供应链使用的术语，已经被更改以反映当前的使用的术语：Supplier organizati
16、on customer供方 组织 顾客The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”本国际标准所使用的术语 组织 取代 ISO 9001 1994中使用的术语 供方，现在使用的供方取代以前适用的术语 “分承包方 ”。Through
17、out the text of this International Standard, wherever the term product occurs, it can also mean “service”.在本国际标准中，当出现术语“产品”时，也能表示“服务”。 3.1 Terms and definitions for the automotive industry3.1 汽车行业的术语和定义For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 20
18、00 and the following apply. 针对本技术规范的目的，适用 ISO9000：2000 和以下给出的术语和定义。However where there are terms for which the wording of the definition differs in ISO 9000: 2000, the definitions given in this Technical Specification apply.但当某些定义与 ISO9000 2000 不同时采用本标准给出的定义。3.1.1 continual improvement3.1.1 持续改进opti
19、mization of characteristics and parameters of a product or process at a target value达到某一目标值,使产品或过程的特性和参数最优。蔡学刚NOTE Continual improvement is only applicable where conformance has been established.注：持续改进只有在符合规定的要求之后才适用。3.1.2 control plan 3.1.2 控制计划documented descriptions of the systems for controlling
20、 parts and processes to provide control of all characteristics important for quality and engineering requirements对控制产品所要求的系统和过程的文件化的描述。3.1.3 design responsible organization3.1.3 具有设计职责的组织organization with authority to establish a new, or change an existing product specification for product delivered
21、 to a customer组织有权限建立新的、或更改现有的产品规范。NOTE This responsibility includes testing and verification of design performance within the customers specified application.注：本职责包括按顾客制定方法进行设计性能的试验和验证。3.1.4 error proofing3.1.4 防错use of product and manufacturing process design and development features to prevent ma
22、nufacture of non-conforming products产品和制造过程设计和开发以防止制造不合格产品。3.1.5 laboratory3.1.5 实验室test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation 进行包括但不限于化学、冶金、尺寸、物理、电性能或可靠性试验或试验在内的检验、试验和校准的设施。3.1.6 laboratory scope3.1.6 实验室范围qualit
23、y record containing the following:受控文件包括(包括如下内容的质量记录): specific tests, evaluations and calibrations that a laboratory is qualified to perform,-实验室有资格进行的规定试验、评价和校准， list of the equipment which it uses to perform the above,-用以进行上述活动的设备清单， list of methods and standards to which it performs the above-进行
24、上述活动的方法和标准清单；3.1.7 manufacturing3.1.7 制造refers to the processes making or fabricating production materials, or production or service parts, or assemblies, or heat treating, painting, plating or other finishing services.进行如后生产或装配的过程：生产原材料、生产件或服务件、装配、热处理、焊接、喷漆、电镀或其它最终服务。3.1.8 outsourcing3.1.8 外部资源proc
25、ess of acquiring product from outside the organization从组织外部获得产品的过程。3.1.9 predictive maintenance3.1.9 预测性维护activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes to prevent disruption of production基于过程数据通过预测可能的失效模式达到避免维护性问题目的的活动。3.1.10 pr
26、emium freight3.1.10 外部资源charges incurred additional to contracted delivery从组织外部获得产品的过程。3.1.11 remote location3.1.11 外部场所location that supports sites and at which non-production processes occur支持现场且没有生产过程发生的场所。3.1.12 site3.1.12 现场location at which value-added production processes occur增值制造过程发生场所。NOTE
27、 1 Includes distributors of parts manufactured by other companies.注 1 包括其它公司制造的零件分销商。NOTE 2 Does not include suppliers of indirect materials, products.注 2 不包括间接材料,产品的供方。3.1.13 special characteristics3.1.13 特殊特性product characteristics or manufacturing process parameters subject to variation which may
28、 affect safety or compliance with regulations, fit, function, performance or subsequent processing of product可能影响安全性或法规的符合性、配合、功能、性能或后续生产过程的产品特性或制造过程参数。4 Quality management system4 质量管理体系4.1 General requirements4.1 总要求ISO 9001:2000, Quality management systems - RequirementsISO 9001:2000质量管理体系-要求4 Qu
29、ality management system4 质量管理体系4.1 General requirements4.1 总要求The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.组织必须按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并
30、持续改进其有效性。The organization shall组织必须：a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),a）识别质量管理体系所需的过程，及其在组织中的应用（见 1.2）b) determine the sequence and interaction of these processes,b）确定这些过程的顺序和相互作用；c) determine criteria and m
31、ethods needed to ensure that both the operation and control of these processes are effective,c）确定为确保这些过程有效运作和控制所需的准则和方法；d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,d）确保可获得必要的资源和信息，以支持这些过程的运作和监视；e) monitor, measure and a
32、nalyse these processes, ande）监视、测量和分析这些过程；f) implement actions necessary to achieve planned results and continual improvement of these processes.f) 实施必要的措施，以实现对这些过程策划的结果和对这些过程的持续改进。These processes shall be managed by the organization in accordance with the requirements of this International Standard
33、.组织必须按本标准的要求管理这些过程。Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.针对组织所选择的任何影响产品符合要求的外包过
34、程，组织必须确保对其实施控制。对此类外包过程的控制必须在质量管理体系中加以识别。NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.上述质量管理体系所需的过程应当包括与管理活动、资源提供、产品实现和测量有关的过程。NOTE When the organization outsou
35、rces, it is not permitted to delegate the technical responsibility.注：组织从外部获得产品时不允许对技术责任授权4.2 Documentation requirements4.2 文件要求4.2.1 General4.2.1 总则ISO 9001:2000, Quality management systems - RequirementsISO 9001:2000, 质量管理体系-要求4.2 Documentation requirements4.2 文件要求4.2.1 General4.2.1 总则The quality m
36、anagement system documentation shall include质量管理体系文件必须包括：a) documented statements of a quality policy and quality objectives,a） 形成文件的质量方针和质量目标；b) a quality manual,b） 质量手册；c) c) documented procedures required by this International Standard,c） 标准所要求的形成文件的程序；d) documents needed by the organization to e
37、nsure the effective planning, operation and control of its processes, andd） 组织为确保其过程有效策划、运作和控制所需的组文件；e) records required by this International Standard (see 4.2.4).e) 本标准所要求的记录（见 4.2.4）NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the proced
38、ure is established, documented, implemented and maintained.注 1:本标准出现 “形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to 注 2 :不同组织质量管理体系文件的多少与详略程度取决于：a) the size of organization and type of activities,
39、 a） 组织的规模和活动的类型；b) the complexity of processes and their interactions, and b） 过程及其相互作用的复杂程度；c) the competence of personnel. c） 人员的能力。NOTE 3 The documentation can be in any form or type of medium.注 3: 文件可采用任何形式或类型的媒体。4.2.2 Quality manual4.2.2 质量手册ISO 9001:2000, Quality management system - Requirement
40、sISO 9001:2000质量管理体系-要求4.2.2 Quality manual4.2.2 质量手册The organization shall establish and maintain a quality manual that includes组织应编制和保持质量手册，质量手册包括：a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),a）质量管理体系的范围，包括任何删减的细节与合理性（见 1.2）b) t
41、he documented procedures established for the quality management system, or reference to them, andb）为质量管理体系编制的形成文件的程序或对其引用；c) a description of the interaction between the processes of the quality management system.c） 对质量管理体系过程之间的相互作用的表述。NOTE The above applies to all the requirements of this Technical
42、 Specification.注：以上适用于本标准的所有要求。4.2.3 Control of documents4.2.3 文件控制ISO 9001:2000, Quality management system - RequirementsISO 9001:2000质量管理体系-要求4.2.3 Control of documents4.2.3 文件控制Documents required by the quality management system shall be controlled. Quality records are a special type of document
43、and shall be controlled according to the requirements given in 4.2.4.质量管理体系所要求的文件必须予以控制。记录是一种特殊类型的文件，必须依据 4.2.4 要求进行控制。A documented procedure shall be established to define the controls needed必须编制形成文件的程序，以规定以下方面所需的控制:a) to approve documents for adequacy prior to issue,a)文件发布前得到批准,以确保文件是充分与适宜的b) to r
44、eview and update as necessary and re-approve documents,b )必要时对文件进行评审与更新,并再次批准c) to ensure that changes and the current revision status of documents are identified,c )确保文件的更改和现行修订状态得到识别d) to ensure that relevant versions of applicable documents are available at points of use,d )确保在使用处可获得的适用文件的有关版本e)
45、to ensure that documents remain legible and readily identifiable,e )确保文件保持清晰、易于识别f) to ensure that documents of external origin are identified and their distribution controlled, andf )确保外来文件得到识别，并控制其分发g) to prevent the unintended use of obsolete documents, and to apply suitable identification to the
46、m if they are retained for any purpose.g )防止作废文件的非预期使用，若因任何原因而保留作废文件时，对这些文件进行适当的标识。4.2.3.1 Engineering specifications4.2.3.1工程规范The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on
47、 customer required schedule. 组织必须建立过程文件以保证及时评审、发放和实施所有顾客工程标准规范以及按顾客要求进度的更改。The organization shall maintain a record of the date on which each change is implemented in production. 组织必须保存每项更改在生产中实施日期的记录。Implementation shall include updates documents. 实施必须包括对所有适当文件的更新。NOTE 1 Timely review should be as
48、soon as possible, and not exceed two working weeks.评审应尽快进行，时间必须不能超过两个工作周。NOTE 2 A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.注：当这些规范在设计记录中引用或如果影响到生产件批准程序文件时，如控制计划、失效模式及后果分析 FMEAs 等等，对这些标准 /规范的更改，要求更新顾客生产件批准的记录。4.2.4 Control of records4.2.4 记录的控制IS0 9001:2000, Quality management system - RequirementsISO 9001:2000质量管理体系-要求4.2.4 Control of records4.2.4 记录控制Records shall be est
